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Thomas Sheidow, Alan Berger, Frederica deTakacsy, Ruihong’ Li, Bonita Rehel, AnneSophie Courseau; Canadian PhIIIb study: ranibizumab combination/monotherapy in visual impairment due to DME: Preliminary Analysis. Invest. Ophthalmol. Vis. Sci. 2013;54(15):4025. doi: https://doi.org/.
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Current standard-of-care for DME, laser photocoagulation, slows progression of vision loss, but rarely results in visual improvement. Based on currently available data, it was hypothesized that patients treated with ranibizumab (alone or in combination with laser) would show greater improvement in BCVA scores than those treated with laser alone. This study evaluated the effect of ranibizumab therapy (alone or with laser) on BCVA over a 12-month period as compared to laser
Eligible patients required a diagnosis of visual impairment due to DME in at least one eye and be eligible for laser. Participants could not have conditions which could interfere with study outcomes or safety. Patients receiving ranibizumab were given 3 consecutive monthly injections, and followed over a 10-month period during which injections were given/held based on stability criteria of the disease. Laser was administered as per ETDRS guidelines at intervals no shorter than 3 months
241 patients were randomized 1:1:1 into 3 arms: 78 were randomized to combination therapy, 81 to ranibizumab monotherapy and 82 to laser monotherapy. In the ITT population (N=212), the mean (±SD) age at baseline was 62 (±10) years, 60% were male and 86% were Caucasian. The mean BCVA score and CRT at baseline were 63.7 (±10) letters and 437 (±141) µm. Treatment groups were comparable. The mean change from baseline to Month 12 in BCVA and CRT was +8.0 letters (95% CI: 5.5, 10.5) and -144µm (95% CI: -182, -106) for the combination arm (n=60), +8.3 letters (95% CI: 6.5, 10.1) and -135µm (95% CI: -170, -100) for the ranibizumab arm (n=62) and +1.1 letters (95% CI: -2.5, 4.6; n=46) and -112µm (95% CI: -157, -68; n=45) for the laser arm. During the trial, the mean number of injections received was 8.5 (±3) for the combination arm (n=71) and 8.6 for the ranibizumab arm (n=74). The mean number of laser sessions was 1.6 (±1) for the combination arm (n=69) and 2.5 (±1) for laser arm (n=69). The most common reason for discontinuation reported was unsatisfactory therapeutic effect in 11% of the laser arm (n=82), 3% of the combination arm (n=78) and 1% of the ranibizumab arm (n=81). 11% of safety patients experienced an SAE (n=214). No fatal event was reported
This preliminary analysis shows ranibizumab (alone or with laser) to be an effective and safe treatment option for visual impairment due to DME.
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